Transcription of IEC 60601-1-2 Medical Devices - Intertek
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IEC 60601 -1-2 Medical DevicesTop 16 FAQs 1. What does the term "Essential Performance"mean?It is quite literally referring to which functions of the product are considered essential. According to IEC 60601 -1: performance of a clinical function, other than that related to BASIC SAFETY, where loss or degradation beyond the limits specified by the MANUFACTURER results in an unacceptable PERFORMANCE is most easily understood by considering whether its absence or degradation would result in an unacceptable Does using either 2nd or 3rd edition make anydevice less safe?
IEC 60601-1-2 Medical Devices Top 16 FAQs 1. What does the term "Essential Performance" mean? It is quite literally referring to which functions of the
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